Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Depressed patients miss a night of sleep (Wake Night), then sleep at predetermined times ending at their desired sleep time. Beginning the morning following their Wake Night, patients sit in front of a bright light, continuing morning bright light and specified sleep time for six weeks with weekly visits measuring depressive symptoms.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Wake Therapy in the Treatment of Depression

NCT01431573

Major Depressive Disorder Bipolar Disorder

COMPLETED NA

Combining Light Therapy and CPAP in Depression

NCT06781593

Major Depression Sleep Architecture Obstructive Sleep Apnea +3 more

RECRUITING NA

Are Bright Lights and Regulated Sleep Effective Treatment for Depression?

NCT03010488

Sleep Phase Rhythm Disturbance Sleep Deprivation

COMPLETED NA

Effects of Light Treatment During Sleep on Young Men

NCT00796939

Depression

COMPLETED NA

Light Therapy for Chronic Insomnia in General Practice

NCT04612192

Insomnia Chronic Sleep Disorder Circadian Rhythm Disorders

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Nonpsychotic, nonbipolar, physically healthy depressed patients keep sleep, mood and energy logs for a week, complete the Morningness-Eveningness Questionnaire (measuring "morningness" and "eveningness") and determine the time patients want to sleep. Patients then miss a night of sleep and subsequently are allowed later and later sleep times until patients are sleeping at their desired time. Beginning the morning following their Wake Night, patients sit in front of bright lights at their intended wake-up time for the next six weeks and once their allowed sleep time is their intended sleep time, patients also continue to only be allowed to sleep between those times (e.g., 11 p.m. to 7 a.m.). Daily sleep, energy and mood logs and activity monitoring are maintained throughout with weekly clinician ratings. In additional, daily telephone check ins occur during the first week following the Wake Night both to be sure the patient is following the protocol and to obtain symptom ratings. Saliva to be measured for melatonin is collected prior to and following sleep adjustment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unipolar Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients receive Chronotherapy, which consists of a night of no sleep ("Wake Therapy") followed by bright lights at their desired sleep time and two nights of Sleep Phase Advance (i.e., sleeping 6 hours earlier than desired for 1 night and 3 hours earlier for the next night, then desired sleep time).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

All patients and staff know what the treatment is.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Triple Therapy

Combined Wake Therapy (one night of missed sleep), early morning bright light and sleep phase advance

Group Type EXPERIMENTAL

Triple Therapy

Intervention Type OTHER

The intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Triple Therapy

The intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Chronotherapeutics

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* major depressive disorder or persistent depressive disorder or unspecified depressive disorder
* physically healthy
* patients over age 60 need primary care physician's approval, electrocardiogram and Mini Mental Status Examination

Exclusion Criteria

* medically unstable condition
* bipolar disorder
* current (past six months) substance use disorder
* significant suicide risk
* need for hospitalization
* history of psychosis

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No